QA Validation Specialist

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in providing development, production and packaging services for pharmaceutical and biotech companies.

For our sterile production site located in Belgium in Brussels (Neder-Over-Heembeek) which is currently expanding its capabilities, we are currently looking for a **QA Validation Specialist.**

The QAValidation Specialist reports to the QA Validation manager

**The Role**

The QA Validation Specialist
- Is acting as prime Quality contact for MS&T (Manufacturing, Science & Technology), Process Validation, Engineering, CSV, Maintenance, and Metrology.
- Is ensuring good relationships with different departments and intensively with MS&T, Process Validation, Engineering, CSV, Maintenance, and Metrology teams.
- Is ensuring review and approval of equipment maintenance, calibration, validation, and qualification records
- Is ensuring review and approval of cleaning validation and process validation records
- Supports and approves investigations
- Provides support during customer quality visits and audits
- Reviews and approve equipment calibration, validation, and qualification records (URS, DQ, FAT, SAT, IQ, OQ, PQ, periodic qualification)
- Provides QA support to NPI (New Product Introduction) projects and related validation activities
- Provides QA support to Q&V (Qualification & Validation) projects and related validation activities
- Provides QA support to Engineering projects and related validation activities
- Participates actively in investigations together with NPI, Q&V, Engineering, Production, Manufacturing, Packaging, Maintenance, QC
- Reviews and approves investigations for deviations, OOS related to validation activities
- Provides support during customer quality visits and audits and during regulatory inspections
- Scientific university degree (Pharmacist, Engineer, or equivalent)
- Experience in working in a GMP environment
- Experience of 3 years in a pharmaceutical / medical device environment in a quality role is preferred.
- Fluent in English, good command of French
- IT knowledge: MS Office (Word, Excel, Outlook), TrackWise
- Knowledge of Quality Management Systems and relevant standards within the pharmaceutical industry: Eudralex - GMP; 21 CFR Parts 210 & 211
- Specific knowledge of GMP regulations on Medical Devices: 21CFR Part 820, ISO 13485

**Position benefits**
- What we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry - a sterile business
- Potential for personal development within an international company
- Defined career path and annual performance review and feedback process
- Contributory pension and benefits package all offered from day one of employment (health/group insurance)
- Meal Voucher, Eco Voucher...
- 36 days’ holiday + bank holidays

**Catalent’s standard leadership competencies that are used to interview and for Performance & Development**:

- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops

**Catalent offre des opportunités enrichissantes pour faire avancer votre carrière** Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour faire la différence.

Catalent s'engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons. À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d'intégration pour assurer la sécurité de tous. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.

Initiative personnelle. Rythme dynamique. Un travail significatif.

Visitez Catalent Careers pour explorer les opportunités de carrière.

Catalent est un employeur garantissant l'égalité des chances et ne fait aucune discrimination sur la base d'une caractéristique protégée par la législation locale.